Package Insert: Information for the User

Micetal 10 mg/g Topical Powder

flutrimazol

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Flutrimazol belongs to a group of medications known as topical antifungals (imidazolic derivatives) used for the treatment of infections caused by fungi and yeasts.

This medication is indicated for adults in the local treatment of the following superficial skin infection:

• Ringworm of the foot (also known as athlete's foot)

Do not use Micetal

• if you are allergic to the active ingredient (flutrimazol), to other imidazolic antimycotics or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Micetal.

For external use only. Do not ingest.

Do not apply to eyes or mucous membranes. In case of eye contact, rinse with abundant water and consult an ophthalmologist if necessary.

Do not use occlusive dressings or those that do not allow for perspiration, as this could favor the development of fungi.

In case of allergic reaction or irritation in the treated area, treatment should be suspended and the doctor consulted.

Adequate hygiene measures should be maintained to avoid contagion and reinfection.

Children and adolescents

Do not apply to minors under 18 years old.

Other medications and Micetal

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, it is preferable to avoid using this medication during the second and third trimesters of pregnancy.During the first trimester of pregnancy, it can only be used when the doctor considers it necessary for the patient's health.

The passage of flutrimazol to breast milk is unknown, so your doctor will decide whether to interrupt breastfeeding or interrupt treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machines

The influence of Micetal on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose and treatment duration foradultsis twice a day (morning and night), for a period of 4 weeks.

Form of Use

Cutaneous use.

Clean and dry the affected areas thoroughly before applying the medication.

Apply the powder gently and uniformly over the affected area and around a healthy area of skin. Sprinkle Micetal powder inside shoes and socks.

If symptoms improve after the first few days of treatment, do not stop treatment until the recommended period indicated by your doctor is completed. If after 4 weeks of treatment symptoms do not improve, consult your doctor again.

General hygiene measures should be taken to control infection sources and prevent possible recurrences.

If you use more Micetal than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you forgot to use Micetal

In case of forgotten dose, wait for the next one. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Micetal

If you interrupt treatment, fungi may not have disappeared. If you have any other questions about the use of this medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

General disorders and administration site conditions

Frequent (≥ 1/100 to <1)

Rare (≥ 1/10,000 to <1)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Micetal

- The active principle is flutrimazol. Each gram of powder contains 10 milligrams of flutrimazol.

- The other components are zinc oxide and cornstarch.

Appearance of the product and content of the packaging

Cutaneous powder. White or almost white powder, odorless, impalpable, adherent.

White polyethylene powder and screw cap, containing 30 grams of powder.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Responsible for manufacturing

Noucor Health, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona – Spain)

or

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet: February 2023.

The detailed and updated information of this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.